Validation Engineer

Scantec Personnel Limited
Negotiable based on experience
08 Oct 2016
20 Oct 2016
Contract Type
Validation Engineer Based in Runcorn Pharmaceutical industry Negotiable salary based on experience A multinational Pharmaceutical company is looking to appoint a Validation Engineer on a permanent basis to their site based in Runcorn. Details: To perform validation activities in accordance with the Validation Master Plan (VMP) and associated validation matrix ensuring that all validation is performed in compliance to GxP with a key emphasise on providing expertise in all aspects of computer system validation. Duties: Execution of all validation related activities, including computer software validation, process validation, facilities and equipment validation. Author and review validation and technical documentation. Act as a QA change owner for GxP systems, including risk identification and mitigation, responsible for tracking changes through to completion. Recommend and manage corrective and preventive actions (CAPAs) to improve compliance. Provide technical support to production to maintain GMP and production efficiency. Complete risk assessments and documentation as required to ensure that the production equipment and production facilities comply with GMP and the relevant HSE guidelines. Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines. Produce / review and maintain Standard Operating Procedures. Prepare and complete product quality reviews to ensure compliance with regulatory requirements and to identify areas for improvement. Undertake other reasonable duties as agreed with the Technical Support and Validation Manager. Assist in the resolution of day to day technical issues with respect to processes and equipment. Ensure compliance with all recognised and relevant standards, internally and externally, to ensure patient safety and in order to comply with legislation as defined by government and statutory bodies. Qualifications and Experience: A degree or equivalent in a scientific or technical discipline. Strong validation background, particularly in computerised systems validation (including GAMP5 principles and Electronic Records and Electronic Signatures regulations). Experience in the validation of small instruments/systems (balances, pumps, isolators etc). Experience in thermal mapping of fridges/freezers/incubators desirable. Clean room experience to at least grade C desirable. Knowledge of microbiology desirable. Experience of facilities validation (HVAC, NVP testing etc) desirable but not essential. For further details and to apply please contact Johnathan Miller at Scantec on 0151._ 666._ 8925 and johnathanm (at) scantec. co. ukScantec is the 3rd Largest Technical Agency in UK - "Recruitment International Magazine 2015" and specialises in the Manufacturing, IT, Technical, Engineering and Scientific Sectors. Scantec provide highly qualified and experienced personnel in a compliant and professional manner on both a permanent and temporary assignment basis. Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website. This job was originally posted as